1. Field of the Invention
The present invention relates to an improved device worn on the user's fingertips for enhancing the sense of touch.
2. Description of the Related Art
Pads constructed of thin layers of plastic sheeting with lubricant in between for use as an aid in breast self-examination (“BSE”) have been known since at least the mid-1980s. See, e.g. Wright, Perry, U.S. Pat. No. 4,657,021 (Reissue 34,353) and U.S. Pat. No. 4,793,354, those inventors doing business as Inventive Products. The devices are placed over the breast to reduce friction and make very small lumps easier to find than would be possible with a bare hand.
Initially there was some controversy when in 1992 the FDA halted sales of these products, classified as medical devices, until clinical testing was completed. The FDA also wanted to make sure that proper information accompanied the product given the importance of its use for early detection of possible breast cancer. Finally in late 1995 the FDA approved Inventive Products' self-examination breast pad, described as a silicon-filled flexible circular plastic envelope 10 inches in diameter. There remains disagreement among medical experts, however. The U.S. Preventive Services Task Force and the Canadian Task Force on Preventive Health in 2002 and 2003 respectively found no evidence that BSE saves lives and do not recommend the practice. Other organizations endorse these products, including the American Breast Cancer Foundation.
Rates of breast cancer in the U.S. were increasing until recently, and the BSE pads have enjoyed some popularity. Improvements on the pads in the form of large mitts or gloves which encapsulated the user's entire hand came along in the late 1990s and more recently. See, e.g. Wright, U.S. Pat. No. 5,946,727, Morrison U.S. Pat. No. 6,506,170 and Becerra U.S. Publication No. 2006/0090243. Beccerra shows a glove worn over the hand, the fingers divided into separate fingered sections of the glove, and a measure of lubricant sealed beneath each finger. This design tends to limit the lateral displacement of the glove during examination, limiting the effectiveness of the examination. Still, the current BSE products being sold suffer from certain disadvantages and can be improved upon to make the devices more effective and less subject to error in use.
The BSE products for sale now are constructed of two layers with the lubricant in between and a third layer, all the layers tied together around the perimeter of the device but leaving an opening for insertion of the user's hand. The problems with this construction are at least fourfold: 1. the user may tend to do the feeling through their less-sensitive hand rather than their fingertips, using the palm area or thumb; 2. the lubricant may easily bunch up somewhere under the user's hands leaving the compressed area without lubrication; 3. the entire device must be moved when examining breast tissue near the perimeter of the device; and 4. the devices are subject to wear and damage at the perimeter seams which are tied together.